Ectopic Pregnancy Biomarkers

NCT ID: NCT00194168

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-06-30

Study Completion Date

2013-11-30

Brief Summary

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In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. The quantification of these (and other proteins) will be performed using the Ciphergen Protein Chip system where serum is sampled with a high-throughput system. The patterns of these peaks will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later goals of the research will be to identify the actual proteins that correspond to the peaks which discriminate between the two clinical entitles. The goal is to identify a unique protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of an ectopic implanted gestation.

Detailed Description

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Conditions

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Ectopic Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Reproductive-aged women
* Currently pregnant based on serum human chorionic gonadotropin level
* Present for care for pregnancy due to vaginal bleeding and/or pelvic cramping
* Final diagnosis of one of the following:

1. Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
2. Diagnosed ectopic pregnancy
3. Ultrasound confirmation of a nonviable gestation (less 14 weeks) such as an anembryonic gestation or a fetal demise

Exclusion Criteria

* None
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt T Barnhart, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Southern California Women's and Children's Hospital

Los Angeles, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Barnhart KT, Guo W, Cary MS, Morse CB, Chung K, Takacs P, Senapati S, Sammel MD. Differences in Serum Human Chorionic Gonadotropin Rise in Early Pregnancy by Race and Value at Presentation. Obstet Gynecol. 2016 Sep;128(3):504-511. doi: 10.1097/AOG.0000000000001568.

Reference Type DERIVED
PMID: 27500326 (View on PubMed)

Rausch ME, Sammel MD, Takacs P, Chung K, Shaunik A, Barnhart KT. Development of a multiple marker test for ectopic pregnancy. Obstet Gynecol. 2011 Mar;117(3):573-582. doi: 10.1097/AOG.0b013e31820b3c61.

Reference Type DERIVED
PMID: 21343760 (View on PubMed)

Other Identifiers

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RRU002

Identifier Type: -

Identifier Source: secondary_id

705016

Identifier Type: -

Identifier Source: org_study_id

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